ClearanceBrief
Panels › Gastroenterology, Urology › Product code FDT · Class 2

Duodenoscope And Accessories, Flexible/Rigid

Regulation 876.1500

2510(k)s in 12 months (35 all time)
8recalls in 12 months (38 all time)
37recalls that name a 510(k)
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Top companies in FDT

DateFirm and productCodeLinked 510(k)
Jul 7, 2026Olympus Corporation of the Americas
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the in
Open, Classified
FDTK220587
Jul 1, 2026Boston Scientific Corporation
CRE Wireguided 18-20mm 240cm
Open, Classified
FDTK110833
Jul 1, 2026Boston Scientific Corporation
CRE Wireguided 15-18mm 240cm
Open, Classified
FDTK110833
Jul 1, 2026Boston Scientific Corporation
CRE Wireguided 12-15mm 240cm
Open, Classified
FDTK110833
Jul 1, 2026Boston Scientific Corporation
CRE Wireguided 10-12mm 240cm
Open, Classified
FDTK110833
Jul 1, 2026Boston Scientific Corporation
CRE Wireguided 8-10mm 240cm
Open, Classified
FDTK110833
Jul 1, 2026Boston Scientific Corporation
CRE Wireguided 6-8mm 240cm
Open, Classified
FDTK110833
Nov 21, 2025Olympus Corporation of the Americas
Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system ce
Open, Classified
FDTK251867
Feb 9, 2024Olympus Corporation of the Americas
Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around t
Open, Classified
FDTK220587
Nov 21, 2023Boston Scientific Corporation
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.
Open, Classified
FDTK193202
Nov 21, 2023Boston Scientific Corporation
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Open, Classified
FDTK193202
Aug 28, 2023Olympus Corporation of the Americas
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Open, Classified
FDTK193182
K202661 +1
May 19, 2023Olympus Corporation of the Americas
Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100
Open, Classified
FDTK193182
Mar 3, 2022Boston Scientific Corporation
EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perf
Open, Classified
FDTK193202
Mar 3, 2022Boston Scientific Corporation
EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perfor
Open, Classified
FDTK193202
Mar 3, 2022Boston Scientific Corporation
EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perf
Open, Classified
FDTK193202
Mar 3, 2022Boston Scientific Corporation
EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perf
Open, Classified
FDTK193202
Dec 10, 2021Olympus Corporation of the Americas
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Open, Classified
FDTK143153
Apr 21, 2021Pentax of America Inc
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic
Terminated
FDTK192245
K210710
Mar 16, 2021Boston Scientific Corporation
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
Terminated
FDTNone listed
Jan 28, 2021Olympus Corporation of the Americas
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps
Terminated
FDTK193182
Feb 20, 2018Pentax of America Inc
Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic ac
Terminated
FDTK092710
K161222
Jul 21, 2017Fujifilm Medical Systems U.S.A., Inc.
FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, st
Terminated
FDTK152257
Jan 17, 2017Pentax of America Inc
Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includ
Terminated
FDTK092710
K963056
Jul 23, 2016Pentax Medical Company
Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; an
Terminated
FDTK963056
Mar 15, 2016Olympus Corporation of the Americas
EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment f
Terminated
FDTK024033
Feb 22, 2016Pentax Medical Company
Video Duodenoscope
Terminated
FDTK092770
Feb 4, 2016Olympus Corporation of the Americas
Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monito
Terminated
FDTK080403
Dec 23, 2015Fujifilm Medical Systems U.S.A., Inc.
Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
Terminated
FDTK042076
Dec 23, 2015Fujifilm Medical Systems U.S.A., Inc.
Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
Terminated
FDTK042076
Dec 23, 2015Fujifilm Medical Systems U.S.A., Inc.
Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
Terminated
FDTK944759
Dec 23, 2015Fujifilm Medical Systems U.S.A., Inc.
Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
Terminated
FDTK944759
Dec 23, 2015Fujifilm Medical Systems U.S.A., Inc.
Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
Terminated
FDTK042076
Sep 22, 2015Olympus America Inc.
EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy
Terminated
FDTK080403
Sep 17, 2015Fujifilm Medical Systems U.S.A., Inc.
Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
Terminated
FDTK042076
K944620
Aug 31, 2015Fujifilm Medical Systems U.S.A., Inc.
Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I.
Terminated
FDTK944759
Mar 9, 2015Fujifilm Medical Systems U.S.A., Inc.
Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, d
Terminated
FDTK152257
Mar 9, 2015Fujifilm Medical Systems U.S.A., Inc.
Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of
Terminated
FDTK152257

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